ModifiedColorado Rocky Mountain Health PlansPolicy IEXD0083.14

Cimzia (Certolizumab Pegol) — Medical Benefit Coverage Criteria (lyophilized powder)

Defines medical benefit coverage criteria for Cimzia lyophilized powder for subcutaneous use (administered by a healthcare provider) across Individual Exchange benefit plans (excludes MA, NV, NY). Applies to Crohn's disease, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and polyarticular juvenile idiopathic arthritis.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyCimzia (Certolizumab Pegol) — Medical Benefit Coverage Criteria (lyophilized powder)

Policy CodePolicy IEXD0083.14

Change TypeClarified benefit assignmentadded prescriber attestationupdated comparator lists

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with prescriber attestation that the patient or caregiver cannot be trained or is physically unable to self-administer Cimzia and provide explanation and documentation of clinical response for continuation.

SourceLink

POLICY UPDATE CHANGES

Policy clarified that this policy refers to Cimzia lyophilized powder for subcutaneous use after reconstitution by a healthcare provider; prefilled syringe for self-administered subcutaneous injection is obtained under the pharmacy benefit.

Added a coverage criterion requiring prescriber attestation that the patient or caregiver is not able to be trained or are physically unable to to administer Cimzia U.S. FDA labeled for self-administration (prescriber must submit explanation).

Updated lists of systemic targeted immunomodulators (added and removed specific agents) across multiple indications to reflect current comparators and prior-therapy requirements.

Removed CPT codes 96372 and 96401 from Applicable Codes.

Added Benefit Considerations section to policy.

12 monthsinitial auth length

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Provider-administeredformulation covered

Prefilled syringepharmacy formulation

All except 3geographic applicability

Coverage Criteria for Cimzia (certolizumab pegol)

Clinical background and benefit considerations

ALL of the following

Background: Cimzia (certolizumab pegol) is a recombinant, humanized antibody Fab' fragment specific for tumor necrosis factor alpha (TNFα). It selectively neutralizes TNFα without an Fc region and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro. Certolizumab pegol does not induce apoptosis in vitro in human peripheral blood-derived monocytes or lymphocytes, nor does it induce neutrophil degranulation. TNFα is a key pro-inflammatory cytokine implicated in the pathology of Crohn's disease and rheumatoid arthritis; certolizumab pegol binds TNFα inhibiting its inflammatory role. Clinical effects include reductions in C-reactive protein (CRP) in Crohn's disease and modulation of inflammatory mediators related to joint destruction in rheumatoid arthritis.
Benefit Considerations: Some Certificates of Coverage allow for coverage of experimental, investigational, or unproven treatments for life-threatening illnesses when certain conditions are met. The member-specific benefit plan document must be consulted to make coverage decisions for this service. State mandates may require coverage for off-label medication uses for certain diagnoses or circumstances; where such mandates apply they supersede language in the benefit document or in the medical/drug policy. Benefit coverage for an otherwise unproven service for treatment of serious rare diseases may occur when certain conditions are met; refer to the Policy and Procedure addressing treatment of serious rare diseases.
Policy scope/operational note: This policy clarifies that it refers to Cimzia (certolizumab pegol) lyophilized powder for subcutaneous use after reconstitution by a healthcare provider. Cimzia prefilled syringe for self-administered subcutaneous injection is obtained under the pharmacy benefit. The policy language replaces references to 'targeted immunomodulator' with 'systemic targeted immunomodulator' and includes a required prescriber attestation (prescriber must submit an explanation) that the patient or caregiver is not able to be trained or are physically unable to administer Cimzia U.S. FDA labeled for self-administration.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for Cimzia (certolizumab pegol) lyophilized powder for subcutaneous use after reconstitution by a healthcare provider. Initial authorizations will be issued for up to 12 months when criteria are met; continuation/renewal authorizations are also issued for 12 months when continuation criteria are satisfied.

Initial authorization duration: 12 months (when criteria met)
Continuation authorization duration: 12 months (when continuation criteria met)

Documentation Required

Prescriber Attestation for Medical‑Benefit Cimzia

The prescriber must attest that the patient or caregiver cannot be trained or are physically unable to self‑administer Cimzia as FDA‑labeled for self‑administration. The attestation must include an explanation and be submitted with the prior authorization request. This attestation is required for initial or continuation requests when the product is provided under the medical benefit (lyophilized powder administered by a healthcare provider).

Applicable Codes

Applicable HCPCS CodesHCPCSCovered

J0717

Injection, certolizumab pegol, 1 mg (code may be used when drug administered under the direct supervision of a physician, not for use when drug is self-administered)

J0717 (definition)HCPCS

J0717

Injection, certolizumab pegol, 1 mg (code may be used when drug administered under the direct supervision of a physician, not for use when drug is self-administered)

Applicable ICD-10 Codes (selected list)ICD-10

K31.6	Fistula of stomach and duodenum
K50.00	Crohn's disease of small intestine without complications
K50.011	Crohn's disease of small intestine with rectal bleeding
K50.012	Crohn's disease of small intestine with intestinal obstruction
K50.013	Crohn's disease of small intestine with fistula
K50.014	Crohn's disease of small intestine with abscess
K50.018	Crohn's disease of small intestine with other complication
K50.019	Crohn's disease of small intestine with unspecified complications
K50.10	Crohn's disease of large intestine without complications
K50.111	Crohn's disease of large intestine with rectal bleeding

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Applicable ICD-10 CodesICD-10Covered

M05.752	Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement.
M05.759	Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement.
M05.761	Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement.
M05.762	Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement.
M05.769	Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement.
M05.771	Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement.
M05.772	Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement.
M05.779	Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement.
M05.79	Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement.
M05.7A	Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement.

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Applicable Codes (removed)CPTNot Covered

96372	Removed CPT code
96401	Removed CPT code

Definitions and Formulation Notes

Medical benefit formulation — Cimzia (provider‑administered)

FormulationCimzia lyophilized powder for subcutaneous use after reconstitution by a healthcare provider (medical benefit)

AdministrationReconstituted and administered subcutaneously by a healthcare provider

BenefitCovered under the medical benefit when criteria are met

Pharmacy benefit formulation — Cimzia (self‑administered)

FormulationCimzia prefilled syringe for self-administered subcutaneous injection (pharmacy benefit)

AdministrationSelf-administration by patient or caregiver using prefilled syringe

Background

Cimzia (certolizumab pegol) is an anti‑TNF biologic consisting of a pegylated Fab' fragment that neutralizes tumor necrosis factor‑alpha. This policy distinguishes the medical‑benefit formulation (lyophilized powder for subcutaneous use to be reconstituted and administered by a healthcare provider) from the pharmacy‑benefit formulation (prefilled syringe for patient self‑administration); the former is subject to the medical policy criteria and prescriber attestation requirements described herein.

Revision History

2026-02-01policy_revisionLatest

Clarified policy applies to Cimzia lyophilized powder for provider-administered subcutaneous use and that prefilled syringe is obtained under the pharmacy benefit; replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator'; added a coverage criterion requiring prescriber attestation that the patient or caregiver cannot be trained or is physically unable to self-administer Cimzia (prescriber must submit explanation).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyCimzia (Certolizumab Pegol) — Medical Benefit Coverage Criteria (lyophilized powder)

Policy CodePolicy IEXD0083.14

Change TypeClarified benefit assignmentadded prescriber attestationupdated comparator lists

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

Required attestation: explanation of inability to self‑administer must be provided by prescriber
Applies to Cimzia lyophilized powder provided under the medical benefit

Denial Risk

Concurrent Targeted Immunomodulator Exclusion

Cimzia will not be covered when used in combination with another systemic targeted immunomodulator for treatment of the same indication. Examples of systemic targeted immunomodulators that must not be used concurrently are listed in the clinical criteria for each indication.

Examples include (not exhaustive): adalimumab; vedolizumab (Entyvio); mirikizumab (Omvoh); upadacitinib (Rinvoq); risankizumab (Skyrizi); guselkumab (Tremfya); ustekinumab; others as listed per indication

Denial Risk

Concurrent Therapy and Documentation Denial Risk

Requests may be denied or recouped if the member is receiving Cimzia in combination with a listed systemic targeted immunomodulator for the same indication or if the required prescriber attestation/explanation is not provided. Lack of documentation of prior failure/intolerance to required conventional therapies may also be a basis for denial.

Denial risk triggers: concurrent disallowed therapy; missing prescriber attestation/explanation; absent documentation of required prior therapy or intolerance

Note

Benefit‑Limited Coverage Risk

Coverage for experimental, investigational, or off‑label uses of Cimzia may be limited by the member's specific Certificate of Coverage or by state mandates. Consult the member‑specific benefit plan to determine whether such uses are allowable; applicable state mandates supersede benefit language.

Member benefit documents determine coverage for experimental/investigational/off‑label uses
State mandates take precedence over benefit language when applicable

Documentation Required

Member Benefit Verification and Benefit Document Precedence

Before approving coverage, verify member‑specific benefits and Certificate of Coverage. If coverage is granted contrary to member benefit terms or applicable state mandates, claims may be denied or recouped.

Verify member benefits and Certificate of Coverage prior to authorization
Claims approved contrary to benefit terms/state mandates may be subject to denial or recoupment

Step Therapy

Step / Try‑Fail Requirements

Initial therapy requires documented history of failure, intolerance, or contraindication to specified conventional therapies or a prior trial of listed systemic targeted immunomodulators where indicated. Specific step/try‑fail requirements vary by indication (see indication criteria for details).

Examples of required prior therapies: corticosteroids, azathioprine, 6‑mercaptopurine, methotrexate, NSAIDs, topical agents, or a 3‑month trial of a non‑biologic DMARD depending on indication
Alternatively, prior treatment with an FDA‑approved systemic targeted immunomodulator for the indication may satisfy initial therapy criteria

Documentation Required

Specialist Prescribing Requirement

Many indications require that Cimzia be prescribed by or in consultation with a relevant specialist (e.g., gastroenterologist for Crohn's disease; rheumatologist for rheumatoid arthritis or PJIA; dermatologist for plaque psoriasis). Ensure specialist involvement is documented in the request.

Specialist prescribing or documented consultation required per indication (gastroenterology, rheumatology, dermatology as applicable)
Include specialist documentation with prior authorization request

Note

Step Therapy Not Specified (Indication‑Specific)

No single, uniform step‑therapy sequence is specified across all indications in this section; providers must follow the indication‑specific prior therapy requirements outlined in the clinical criteria and submit supporting documentation.

Follow indication‑specific prior therapy rules; no universal step‑therapy ladder is provided here

Billing Rule

Prior Therapy / Concomitant Therapy Restrictions

Prior therapy and concomitant therapy restrictions are applied across indications; patients must not be receiving disallowed systemic targeted immunomodulators for the same indication at initiation or during continuation. Updated lists of examples by indication are provided in the policy history and clinical sections.

Do not use Cimzia with the listed systemic targeted immunomodulators for the same indication
Refer to the indication‑specific lists (policy text and history) for the most current examples

Obtained and covered under the pharmacy benefit; not governed by this medical‑benefit policy

J0717 — HCPCS code

HCPCS codeJ0717 — Injection, certolizumab pegol, 1 mg

Use caseCode may be used when drug is administered under the direct supervision of a physician

Not forNot to be used for self-administered prefilled syringe dosing

Certolizumab pegol (Cimzia) — drug descriptor

Generic nameCertolizumab pegol (Cimzia)

Molecular typeRecombinant, humanized antibody Fab' fragment (pegylated) lacking an Fc region

MechanismBinds and selectively neutralizes tumor necrosis factor alpha (TNF‑α)

TNF‑alpha — brief definition

DefinitionTNF‑alpha — a key pro‑inflammatory cytokine involved in upregulating adhesion molecules, chemokines, MHC expression, and other inflammatory mediators

Clinical relevanceElevated TNF‑α implicated in Crohn's disease and rheumatoid arthritis pathophysiology

Pharmacologic targetPrimary target neutralized by certolizumab pegol to reduce inflammation

Certolizumab pegol (Cimzia) — alternate descriptor

Generic nameCertolizumab pegol (Cimzia)

PropertiesRecombinant, humanized Fab fragment, pegylated, lacks Fc region and does not fix complement or cause ADCC in vitro

Clinical effectNeutralizes TNF‑α leading to decreased inflammatory mediators and reductions in CRP observed in Crohn's disease

Benefit Considerations

Plan precedenceMember‑specific Certificate of Coverage and benefit plan documents must be consulted and may supersede this policy

State mandatesApplicable state mandates for off‑label or mandated coverage supersede policy language where they apply

Pharmacy vs MedicalPrefilled syringe (pharmacy benefit) coverage or state/plan requirements may differ from medical‑benefit rules for provider‑administered formulation